Recor medical paradise® renal denervation system

Abstract

The ReCor Medical Paradise® Renal Denervation System delivers ultrasound energy to perform targeted circumferential denervation to the renal afferent and efferent sympathetic nerves with the goal of achieving a reduction in systemic arterial blood pressure, and mitigating end organ effects due to sympathetic over-activity. Ultrasound energy is a controllable energy source which does not require direct tissue contact to heat the tissue providing a unique therapeutic advantage in the application of renal denervation. The Paradise System has been designed to deliver energy to create an optimized tissue thermal profile to achieve targeted ablation of nerves surrounding the renal artery, while preserving the integrity of the renal arterial wall through a unique cooling mechanism. The tissue thermal profile has been optimized through pre-clinical in vitro and in vivo testing. Feasibility clinical studies have demonstrated the safety and effectiveness in controlling resistant hypertension of the system out to 12 months. On-going and future clinical studies will allow for a continued assessment of the overall safety, effectiveness, and durability of the Paradise System.